DRG SOFTRELEASE

K041018 · Doctor'S Research Group, Inc. · HHT · Oct 18, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K041018
• Device Name: DRG SOFTRELEASE
• Applicant: Doctor'S Research Group, Inc.
• Product Code: HHT · Obstetrics/Gynecology
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD).

Device Story

DRG SoftRelease is a single-use, disposable, manual gynecological instrument for cervical cell collection. Device consists of a handle with a release mechanism and interchangeable attachments: a brush (bristles on a wire shaft) and a plastic, curve-shaped spatula. Physician or clinician operates device in a clinical setting. For brush use, device is inserted into the cervix, rotated once, and removed. For spatula use, the blunt edge is placed against the cervix, rotated, and removed. Collected cytological material is transferred for analysis. Device facilitates sample collection for Pap smears and STD testing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual gynecological instrument; plastic spatula and wire-bristle brush attachments; single-use; disposable.

Indications for Use

Indicated for the collection of cervical cells for Pap smear analysis and/or detection of sexually transmitted diseases. Contraindicated for use in pregnant women.

Regulatory Classification

Identification

An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes. (2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant. (3) An umbilical clamp is an instrument used to compress the umbilical cord. (4) A uterine curette is an instrument used to scrape and remove material from the uterus. (5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix. (6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus. (7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination. (8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix. (9) A gynecological cerclage needle is a looplike instrument used to suture the cervix. (10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus. (11) A gynecological fibroid screw is an instrument used to hold onto a fibroid. (12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity. (13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina. (14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures. (15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus. (16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis. (17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina. (18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.

Special Controls

*Classification.* (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.

Predicate Devices

• Rovers Spatula (K002520)
• Digene Cervical Brush (K971586)

Submission Summary (Full Text)

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15 K041018

# OCT 1 8 2004

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Doctors Research Group, Inc.

'physicians working together

### Premarket Notification 510(k) Summary of Safety and Effectiveness DRG SoftRelease

#### Submitter:

Doctors Research Group, Inc. 50 Altair Avenue Plymouth, CT 06782 (tel) 860-283-1479 (fax) 860-283-1589

Establishment Registration Number: 1226001

#### Contact Person:

Edward H. Goldman Doctors Research Group, Inc. 50 Altair Avenue Plymouth, CT 06782 (tel) 860-283-1479 (fax) 860-283-1589

### Summary Preparation Date

April 9, 2004

#### Device Information

| Trade name: | DRG SoftRelease |
|------------------------------|--------------------------------------------------------------|
| Common name: | Cervical Cell Scraper / Sampler |
| Classification name: | Cytological Cervical Spatula |
| Device Classification Panel: | Obstetrical - Gynecological Specialized Manual<br>Instrument |
| Regulation number: | 21CFR Part 884.4530 |
| Class: | II |
| Product Code: | HHT |

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## 510(k) Summary (continued)

Predicate Device

| Rovers Spatula | K002520 | Rovers Medical Devices BV |
|-----------------------|---------|---------------------------|
| Digene Cervical Brush | K971586 | Digene Corp. |

### DRG Device Description

The DRG SoftRelease is a single use, disposable, manual gynecological device intended for the The DNO of cervical cells for Pap smear analysis and/or for detecting sexually transmitted concellon of on noal oulle for a handle with a release mechanism, a spatula discuse (o r b). The donto common handle / release combination allows the attachment, of a brush attach how h for use in cervical or vaginal wall cell collection. The attachnent of oknor the opatals of the cell collector attachments from the device handle.

The brush is composed of bristles joined to a wire shaft. For collecting cervical cells, the brush is inserted into the cervix until only the last row of bristles are visible, rotated once via the handle, and removed from the site for transfer of the cytological material.

The spatula is made of plastic and is curve-shaped, similar to the widely uses Ayre spatula. For r ric opatilia is made of the spatula's blunt edge is placed against the cervix, rotated with gentle oonooting on the handle, and removed from the site for transfer of the cytological material.

#### Intended Use

DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or for detecting sexually transmitted disease (STD).

#### Basis of Equivalence

The DRG SoftRelease is substantially equivalent to the Rovers Spatula and Digene Cervical Brush based on the indications for use, design, materials, and principles of operation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 1 8 2004

Mr. Edward H. Goldman Director, Quality Assurance Doctors Research Group, Inc. 50 Altair Avenue :PLYMOUTH CT 06782

Re: K041018

Trade/Device Name: DRG SoftRelease Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument

Regulatory Class: II Product Code: 85 HHT Dated: August 11, 2004 Received: August 16, 2004

·Dear Mr. Goldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 910(t) prohentially equivalent (for the indications for use stated in above and have determined the devices marketed in interstate commerce prior to the enclosure) to regally marketed predical Device Amendments, or to devices that have been May 28, 1970, the clacultion date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of application (PMA). You may, therefore, market the do not require approval of a prematics approvide approvide (The general controls provisions of the Act. device, subject to the general controls provinsities, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classifica (Sec above) into existing major regulations affecting your Approval), It may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA device can of tound in the coments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s issualled of a succeannality with other requirements of the Act of any FDA has made a delemination adal 10. 10. 10. 10. 1. 0. must comply with all the Federal statues and regulations administered of occistration and listing (21 CFR Part 807); labeling Act's requirements, including, but not minted to regulations as set forth in the quality systems (QS) (21 CFR Fart 801), good manatalating product radiation control product radiation control provisions (Sections 531-542 of the Act). 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin harketing your aver of your device of your device to a legally premarket notification. THE FDA Intention of Sactian vija
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device of our has lastering organ.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation emilities, "Thisotanas on your responsibilities under the Act from the 807.97). You may outer general international and Consumer Assistance at its toll-free number (800) DVNSon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Doctors Research Group, Inc. 50 Altair Avenue Plymouth, CT 06782 [phone]

# Statement of Indications For Use

510(k) Number (if Known): 7

Device Name: DRG SoftRelease

Indications for use:

DRG SoftRelease is intended for the collection of cervical cells for Pap smear analysis and/or DRG SoftRelease is intended for the oblicolion of convice is not intended for use in pregnant women.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Рег 21 CFR 801.109)

OR

Over-The-Counter Use

Nancy C Broadon

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devi 510(k) Number_